L011-1007 Rev D1.indd
Contents
1. 6ea SAA 6ea SBB SEE 6ea SCC 1ea LL 1ea KK 2 ea SDD BACK TOP 70 AC AR STar Array Locking Carrier includes 1ea SA w 2 spare screws DA 44970R Sterile Array Tungsten Platform mT Electrode pk 5 44975Z Sterile Array Tungsten Platform mT Electrode D ZAP pk 5 44975L Sterile Array Tungsten Platform mT Electrode D ZAP Leadpoint pk 5 SA STar Array Locking Carrier w 2 ext 40CM Lead ar Array Locking Carrier w 2 extra screws SB STar Array Hex Wrench Implant SC STar Array Wire Tool SAA STar Array Platform Insertion Guide Tube O E SBB STar Array Platfrm Electrode Insertion Tube SCC STar Array Platform Electrode Insertion Tube Stylet SDD STar Array Insertion Tube Extractor kl SEE Array Platform Electrode pin positions2. 70 IT ARP Sterile STar Array Electrode Insertion Tube pk 5 includes 5ea SAA 5ea SBB and 5ea SCC 66 IT 1019 FC1019 Sterile lead Insertion tube pk 5 includes 5ea KK 5ea LL 70 CN ET C307 Sterile STar Array Insertion Tube Extractor pk 5 includes 5ea SDD 70 IT AR Non Sterile STar Array Electrode Insertion Tube Set includes 6ea SAA 6ea SBB 6ea SCC 2 ea SDD 1ea LL 1ea KK 70 AC AR C8008 STar Array Locking Carrier includes 1ea SA w 2 spare screws Tea SB FC1003 Non Sterile Array mT Electrode pk 5 22670 Sterile Array mT Electrode pk 5 22675L FC2001 Sterile Array mT Electrode pk 5 DZAP Leadpoint 22675Z Sterile Array mT Electrode pk 5 DZAP 70 IT AR j SA STar Array Locking Carrier w 2 extra screws Non Sterile 1leakKk SB STar Array Hex Wrench eaLL SC STar Array Wire Tool 6ea SAA SAA STar Array Insertion Guide Tube 6ea SBB
3. KK Ordering information FHC Medtronic LL 70 17 7107 FC9001 Sterile STar Array Electrode Insertion Tube SAA Nexframe STar Drive pk5 includes 5ea SAA 5ea SBB 5ea SCC l j 70 IT 7147LI FC9002 Sterile Lead Insertion Tube Nexframe STar Drive pk5 includes 5ea KK 5ea LL SDD 70 CN ET FC8011 Sterile STar Array Insertion Tube Extractor pk5 includes 5ea SDD BACK SEE AC 70 AC AR FC8008 STar Array Locking Carrier er TOP SA 70 AC AR includes 1ea SA w 2 spare screws 1ea SB e VIEW fa N 5700R Sterile Nexframe STar Drive mT Electrode pk 5 ei ge A LA We Ju o 1 5705L FC2004 Sterile Nexframe STar Drive DZAP Leadpoint mT Electrode pk 5 KO Ne A ULSI 5705Z Sterile Nexframe STar Drive DZAP mT Electrode pk 5 T HUIS SA STar Array Locking Carrier wl 2 extra screws 7 SB STar Array Hex Wrench wir SC STar Array Wire Tool SE SB SAA STar Array Nexframe Insertion Guide Tube E SBB STar Arr
4. 3 Holding the non sterile assembly with the pins pointing away from you and the coiled cable in the same hand slide it into the drape being careful not to touch the outside of the drape 4 Push the drape over the hand so the assembly and cable are all the way at the end of the sleeve Note that the draping process results in the alignment and motor drive pins which are non sterile protruding from the sterile drape de or prior to putting on sterile gown and gloves Remove the protective storage cap from the Coupling Unit To remove any debris wipe the WARNING After draping the accessories do not alignment and center drive pins with an isopropyl touch the mounting or drive plate pins against alcohol dampened lint free cloth or wipe Coil the any sterile field elements These pins should assembly s cable and place it on a flat surface so only be allowed to contact the top of the STar that it can be picked up with its cable in one hand Drive M E and will be inaccessible when fully assembled 5 and Maneuver the drape and assembly so that the two alignment pins and the center drive plate are entering the cutouts in the end of the drape 2 Remove the drape from its sterile pack aging and expand the opening to allow entry of a hand Do not pull any of the folds out at this time If one person remove the included elastic bands from their tape holder and place on a sterile sur face LO1
5. B Die EE D PP Power Assist with Display Assembly motor 66 DA ME E Drive advancement knob REN ME version only O QQ Position Display Assembly encoder 66 DA EN 02 F Stereotactic positioner locking knob Ze PA RR Power Assist Controller Display Module 66 EL MS G Lower Guide for 70 ZD ME only 70 LG 01 SL LY SS Power supply H Lower guide locking knob WE version only eg Spare knobs TT Power Cord STar Drive manual 70 ZD MA UU Remote Control 66 EL RM J STar Drive Motor Encoder 70 ZD ME K Cleaning brushes 66 CN BR WW Sterile Drapes Sleeves 66 DA SD L STar Steri Suite 67 00 7 XX Storage Case 66 DA SC M Lead Holder 70 CN DB includes MO N Lead measurement fixture 7T0 AC MT el SI Spare IH 1 I Io IN Inn O 1 8 mm Depth Stop Adapter 66 AC DS 1 8 P Protection Cover IWE version only E inf S Q Accessory locking knobs M E version only ncoder Option Ordering information Po N Frame Adapters one needed but not included Ordering Information 66 DS PD includes QQ RR SS TT XX A gt S STar Frame Adapter for Leksell Stereotactic System w lower arm bushing 70 FA LX FC8003 66 DA SD Sterile pack 20 WW S Se T STar Frame Adapter for Radionics CRW 70 FA RD FC8004 oe U STar Frame Adapter Leibinger RMTM 70 FA RM FC1007 mel RR TT XX ww V STar Frame Adapter for Leibinger ZDTM 70 FA ZD FC8006 Ss IS u FC1004 0 a W STar Frame Adapter for BrainLAB MICROMAR 70 FA BL _ yk A sen H NR YY STar Offset Frame
6. Soak all components in wash solution then repeat step one as above then rinse in distilled water Insertion Tubes Spacer Tubes and Stylets MUST be steam sterilized as separate items not assembled microTargeting STar Drive System Directions for Use Automated Cleaning Use tray with disassembled components page 5 Drive and its Recirculation Water Ecolab Inc Ecolab GmbH Components Time min Temperature detergent detergent ONLY 2 5 ml l or 1 4 oz gal 2 5 ml l or 1 4 oz gal 2 GC Tap Water SteriSuite cover removed J case rd Hot Tap Water Asepti Wash needed TTT a 43 C minimum Plus SERGE L Lead Holder M Electrode Wash 1 2 00 a dee wasn Sekusept AR Depth Stops Es 0 Y X SA SB a Rinse 1 2 00 pare Wate N A N A Measuring Fixture N 66 0 C a 2 Rn Pure Water Heated Asepti Rinse Sekusept FNA or BER Rinse ur 0 C Sekumatic Multiclean Verification Probe A Dry Phase Sterilization WARNING The use of unvalidated sterilization protocols could result in damage to components and affect their functioning or performance Method Container Protocol Prevacuum Wrapped Gravity Wrapped preconditioning pulses 3 minimum temperature 132 C 270 F minimum temperature 132 C 270 F full cycle time 30 min full cycle time 12 min minimum dry time 35 min minimum dry time 30 min Prevacuum Wrapped Gravity Unwrapped preconditioning pulses 3 minimum temperature 132
7. 188 5 mm 160 mm LO11 1007 Rev D1 February 2012 39 Leksell Stereotactic System Adapter 103 93 Stockholm Sweden Elekta AB Birger Jarlsgatan 53 Box 7593 SE 292 5 mm micro Targeting STar Drive System Directions for Use 40 Leibinger RM Adapter Stryker Leibinger GmbH amp Co KG Botzinger Stra e 41 D 79111 Freiburg Germany SE n ur L ka la T 30 mm E 2 2 3 3 from Target 292 5 mm 41 1011 1007 Rev D1 February 2012 Leibinger ZD Adapter Stryker Leibinger GmbH amp Co KG B tzinger Stra e 41 D 79111 Freiburg Germany with different instrument holders Refer to the Oo D gt O gt Bi o el oO gt m N b eil E 2 D I g Z D S Leibinger ZD User Manual to confirm settings Failure to do so may cause a deviation from the planned target point 294 mm 190 mm microTargeting STar Drive System Directions for Use 42 micro Targeting Platform Adapter 43 LO11 1007 Rev D1 February 2012 Single Electrode Platform configuration 66 IT 03 Ordering information 66 AC AR Non Sterile Array Carrier and Clamp Includes GG HH II 66 IT 03P Sterile Single Insertion Tube Set Includes AA BB CC 66 IT 03 Non Sterile Single Insertion Tube Set Includes AA BB CC DD EE FF 44970R Sterile Tungsten Platform mT Electrode pk 5
8. 44975Z Sterile Tungsten Platform mT Electrode D ZAP pk 5 44975L Sterile Tungsten Platform mT Elec D ZAP Leadpoint pk 5 mTDPBN BP MP1 Non Sterile Pt Ir Platform Single mT Electrode pk 6 BACK Insertion Tube NN i TB 66 AC AR Stylet 5 NS Spacer Tube for tungsten microelectrodes 2 VIEW 4 BR Spacer Tube for Pt Ir microelectrodes a Tungsten microelectrodes Spacer cleaning Rod FRONT Pt Ir microelectrodes Spacer cleaning Rod 40CM Lead Array Electrode Carrier Implant Shielded Array Clamp Non shielded Array Clamp O HH SIDE Single tungsten mT electrode VIEW Single Electrode pin position in slot ege Verification Probe Lead
9. Holder 70 CN DB z Il Measuring Fixture 70 Ac MT 01 Depth Stop Adapter 1 8 mm 66 AC DS 1 8 i MA Drive shown with 120mm model mT platform Drive at Zero Drive at Target M DD ccPB AA MM z SECH zZ Sc hi Va m Ta I DO COE S E 10 cc 15 o gt 0 55 mm SES Kaes 36 40 GE E j f N 1 60 1 83 mm q AID 319mm 0 99 1 5 mm lc fei N Se ie OA EE 206 74mm CG j CT Lo S A Macro e Es Contact i SCH J 27 mm 01 Si S E 28mm gn E Pe E Ki e 10 mm ta D Drive at Zero Target I E Drive at Target Target 44 microTargeting STar Drive WE System Directions for Use STar Array Electrode Platform configuration 70 IT 04 Non Sterile Ordering information i 70 IT AR5P Sterile STar Array Electrode Insertion Tube pk 5 includes SAA 5ea SAA 5ea SBB 5ea SCC l SBB 66 IT AR4P Sterile Lead Insertion Tube pk 5 includes 5ea KK 5ea LL scc 70 CN ETSterile STar Array Insertion Tube Extractor pk 5 includes 5 ea SDD o on 70 IT 04 STar Array Electrode Insertion Tube Set for mT Platform includes
10. Loosen the screw s of the carrier holding the remaining Insertion Tube s LO11 1007 Rev D1 February 2012 33 22 Remove the remaining Insertion Tube s 24 Tighten the screw of the carrier to secure by inserting the Tube Extractor with the lead Insertion Tube slight force into the Insertion Tube and pulling upwards 23 Repeat step 22 to remove the remaining 25 Remove the Stylet guide tubes 34 micro Targeting STar Drive System Directions for Use 28 Secure the Depth Stop Adapter 1 8mm in the Lead Holder 26 Attach the Lead Holder to the Drive positioning platform 29 Confirm the lead location Use the remote control if a motor is attached otherwise turn the knob WARNING Observe the exposed segment of the lead while advancing the Drive and ensure it advances into the Insertion Tube without binding or bending 27 Insert the preset lead into the Insertion Tube LO11 1007 Rev D1 February 2012 35 amp Remove the Drive and Insertion Tube aa Za ta un Pre 33 Remove the Stylet from the lead 30 Loosen the screw holding the lead Insertion Tube Ir a Wen 34 Loosen the Depth Stop Adapter 1 8mm screw 31 Raise the lead Insertion Tube 35 Hold the lead with smooth tip rubber coated tweezers next to the skull or use the lead locking device 32 Hold the lead with smooth tip rubber coated tweezers next to the sku
11. be carefully inspected before use because damage to them can cause targeting errors and impact patient safety Handle Insertion Tubes and Spacer Tubes carefully to prevent bending Lg WARNING Check to be certain that tubes are straight with the collar over the edge roll the Insertion Tube over a flat surface or in the Measuring Fixture slot Pre Use Assembly and Checkout continued 6 Install the Verification Probe onto the positioning platform tighten the locking screw When the stereotactic system and the Drive are set up correctly the tip of the Verification Probe will be exactly at the predicted target Ifthe stereotactic system used has a phantom confirm the targeting coordinates at this step If not proceed WARNING The verification probe should never enter the brain 5 Secure the Stereotactic Adapter to the Drive See pages 39 52 for appropriate type 7 Remove the Verification Probe 10 microTargeting STar Drive System Directions for Use Motor Encoder Accessories Sterile Draping Draping the Assembly can be accomplished by one per son but is facilitated if an assistant is present The one person method will require a sterile gloved hand STERILE for the drape The other hand will be a non sterile hand STERLE after handling the module Most will find that the module hand should be the least favored hand A practice draping should be done before first surgical use
12. to Zero button on the Remote Control is inadvertently pressed for at least 5 seconds before the next step the Module will go into its Remote calibration mode The calibration procedure described on page 16 must be followed before the Remote will function normally For the Encoder Assembly advance or retract the Drive using the advancement knob For the Motor Assembly turning the Remote Con trol knob clockwise advances the Drive towards the target turning the knob counterclockwise retracts the Drive away from the target location The further the knob is turned the faster the Drive will advance or retract Full clockwise position will advance the Drive at the highest possible speed full counterclockwise position will retract the Drive at highest possible speed If there is any movement of the Drive when the Remote Control knob is in the center resting po sition follow the calibration procedure on page 16 AN WARNING Be careful when moving the Drive above the zero mark or below 50mm prior to pressing the zero button It is possible to move the Drive into its physical limits Care fully observe travel direction when using the Remote Control before the Drive is zeroed After the Drive is zeroed the Controller will not allow movement beyond the Drive limits of 0 00 and 50 0mm CAUTION Never turn the manual advance ment knob on the microTargeting STar Drive M E while a motor is engaged This can damage both t
13. to use the microTargeting STar Drive System should be completely assembled and correct operation verified to ensure that all components function properly Improper set up of equipment may lead to serious patient injury Lg WARNING Always confirm the tightness of thumbknobs especially those holding the frame adapter before beginning the procedure The stereotactic adapter must be securely held in the frame mount so that the drive system cannot move or rotate Cautions Ea CAUTION The microTargeting STar Drive M E System Motor and Encoder Accessories are specifically designed to be used with the microTargeting STar Drive M E Use with other components or systems is not authorized and may result in mechanical failure or injury CAUTION Federal law restricts this device to sale by or on the order of a physician CAUTION FHC s regulatory clearance requires that microTargeting STar Drive Systems and components be factory evaluated by an authorized representative on an annual basis or serviced and recalibrated every 100 uses whichever comes first CAUTION Do not use non approved stereotactic system adapters insertion tubes or other medical or electronic devices with the microTargeting STar Drive System CAUTION Handle the Drive and when applicable its Motor and Encoder Accessories with extreme care These components may be damaged if excessive force or incorrect handling occurs CAUTION The Drive Sy
14. 1 1007 Rev D1 February 2012 11 KI Motor Encoder Accessories Sterile Draping continued 9 Unfold the drape carefully as the cable is withdrawn When the cable is out of the sterile envelope distance the hand can hold both the cable and the drape 6 and Push the pins and the center drive plate through the cutouts and smooth the stretchable end of the drape over the assembly 10 Using the tape that the elastic bands came in pull in the folds of the drape tightly above the assembly and tape neatly If no assistant is helping this can be done after changing the non sterile glove 7 Take the elastic bands and stretch them over the assembly using at least two wraps Be careful to smooth any wrinkles from the mating flat surface of the assembly as this is done Do not touch the pins or drive plate Ensure the wraps are above the flanges on the assembly to prevent slipping The whole draped apparatus set aside on a sterile surface awaiting the surgery In this case it is best to leave the cable inside the drape and to not unfold the drape more than necessary until it is needed 11 The assembly cable can be plugged into its receptacle or 8 Hold the drape with the assembly inside while hand pulls the cable from the drape Be careful not to touch the pins protruding from the end of the drape 12 microTargeting STar Drive System Directions for Use Motor Encoder Accessories Mounti
15. 6 IT 05P C1036 Sterile Single Electrode Insertion Tubes includes AA BB CC 66 IT 07 15mm pk 5 20 mm above target 66 IT 14 10mm 34685Z Sterile single mT electrode pk 5 DZAP IT NT 346851 C2002 Sterile single mT electrode pk 5 DZAP Leadpoint 66 11 08 t larget FC1011 Non Sterile Single Electrode Insertion tube Kit includes FC1002 Non Sterile single mT electrode pk 5 ar GI 40cm Lead Implant 34680 Sterile single mT electrode pk 5 TY TTY X Shielded Single Electrode Carrier 66 IT 01 Non Sterile Y STar Single Electrode Carrier AA Z Single mT electrode Medtronic 34680 FC2002 BB Oa 7 FHC 34685L Z E AA Insertion Tube 66 IT 01 shown CC BB Stylet di CC Spacer Tube DD Lu DD Spacer Cleaning Rod l MA Drive shown with STar Frame Adapter for Leksell Stereotactic System S Drive at Zero Drive at Target M Anm Sn y ch N d joo er 7 S BB AA o CC i 50 5 50 vl 1 60 1 83mm C P e 375 mm 0 77 mm Ce Lk 8 0 99 J 1 5mm l 262 5 f o MM N N 188 5 mm 8 A Macro Contact ae 40 mm 10 mm i i Ob j ae 10 mm Se Drive at Zero a n 30 mm l om Sen I er E Drive at Target Se Sy Target 20 Dimensions may vary for other adapters
16. Adapter for Leksell Stereotactic System 70 FA LX 01 Y d P N we J ZZ STar Offset Frame Adapter for Radionics CRW 70 FA RD 01 a STar microTargeting Platform Adapter Kit not shown 70 FA SF D TM PETO STar Frame Adapter SC Wale STar Frame Adapter STar Frame Adapter for Leksell R S ics CRW Leibinger RM for Leibinger ZD Stereotactic System adionics U V with Lower Arm Bushing T e zZ i rT hilanhaan aa M i gi nt Le Di J Bn _IDDD 000000000000 m i SS pee Ey STar Frame Adapter A STar Offset Frame STar Offset Frame Adapter micro Targeting STar Drive System A AS uul 7 for BrainLAB MICROMAR Adapter for Leksell for Radionics CRW ordering information I OA al Stereotactic System _ ee LD ST DS MA FC8001 includes I A K L N SE a GE PR AN ON microl argeting AO gt Fr o d gt SE Remote Control u Nag roy ST DS ME C8002 includes J A K L N SS eh A TER 8 SL a j KH PP N Optional Equipment 3 end e G Lower Guide for use with 70 ZD ME only 70 LG 01 FC3007 _ Motor Option Ordering information gain j N G gt 66 DS PA includes PP RR SS TT UU XX e pee N i 66 DA SD Sterile pack 20 WW E gt ke Pedy FC1008 includes PP RR SS TT XX N a i FC1004 Sterile pack 20 WW See reverse for Insertion Tube and microelectrode Sets Single and Array 19 LO11 1007 pg 19 amp 20 Rev D1 February 2012
17. C 270 F minimum temperature 132 C 270 F full cycle time 10 min full cycle time 4 min minimum dry time 20 min Following sterilization before reassembling the Drive System use a cloth dampened with sterile distilled water to wipe off surfaces to prevent residue build up The system should be examined after each sterilization cycle for damage and function LO11 1007 Rev D1 February 2012 Maintenance and Calibration of the Drive All components of the Drive should be thoroughly cleaned then rinsed with distilled water following each use None of the system s moving parts require lubrication Do not oil or lubricate Before each use thoroughly examine the micro Targeting STar Drive System for function cleanliness and calibration Any noticeable change in accuracy in ease of movement or any buildup of residues looseness damage or difficulty of fitting components will require return to the manufacturer for refurbishing and recalibration Specifications Usability Drive Platform Travel 50 mm graduated in 1mm increments from 0 to 50 mm Drive advancement knobs 1mm movement revolution 0 025mm graduation Array spacing 2 00 mm from center Array guide hole diameter 1 88mm Electrical requirements Controller module 100 240 volts 50 60Hz 0 8 Amps Emitted Radiation All electrical components have been tested to certify they meet requirements of ISO 60601 Pre Use Assembly and Checkout WARNING
18. FHC aA D micro Targeting STar Drive System Directions for Use Including Motor Assembly Encoder Assembly Controller Display Module Stereotactic Adapters LO11 1007 Rev D1 February 2012 FHC Inc Fr FHC Europe 1201 Main Street EC REF TERMOBIT PROD srl Bowdoin ME 04287 129 Barbu Vacarescu Str Sector 2 Fax 1 207 666 8292 Bucharest 020272 www fh co com Romania 24 hour technical service 1 800 326 2905 US amp Can 1 207 666 8190 microTargeting Innovation through collaboration FHC Latin America Carrera 43 A 1sur 31 Ed BBVA oficina 401 Medellin Colombia M micro Targeting STar Drive System Directions for Use Contents co d Oo 0 OO Ff 8 10 11 12 13 14 14 16 16 17 18 19 20 21 27 28 37 38 39 40 41 42 43 45 46 47 48 49 51 52 53 53 Directions for Use of the STar Drive M E and Manual version are similar Illustrations herein show the M E version with accessories Manual drive users should disregard the sleeved Motor shown in pictures and any eh Warnings and Cautions Symbols Storage Sterilizable components Disassembly for cleaning and or sterilization Cleaning of sterilizable components Manual Automated Sterilization Maintenance and Calibration Specifications Pre Use Assembly and Checkout Motor Encoder Accessories Sterile Draping Motor Encoder Accessories Mounting the Draped Assembly Motor Encoder Accessories Controller Dis
19. If any error or erratic function is observed discontinue use of the Drive immediately and evaluate the potential impact to patient safety before continuing its unmitigated use WARNING While often snug all tubes used with the microTargeting STar Drive System have been designed to be inserted and removed by hand or by using the STar Insertion Tube Extractor Any other tool should be used only as a last resort and indicates system repair may be necessary WARNING Do not use the STar Insertion Tube Extractor with any other tube than the STar Array Insertion Tube ws 1 Confirm there are no contaminants or debris on the Drive Turn both knobs separately confirm that the Drive screw rotates and that the electrode platform moves Confirm that there are no stiff spots skipping free play or backlash present when turning the knob Confirm that the knob s turn easily without excessive resistance microTargeting STar Drive System Directions for Use STar Drive M E STar Drive 2 Confirm all thumbknobs are present LO11 1007 Rev D1 February 2012 Pre Use Assembly and Checkout continued uf A 3 If using the 40cm lead test mount the Lead Holder on the positioning platform confirm there are no stripped threads or looseness 4 Inspect the Insertion Tubes WARNING As the most critical component of a procedure delicate Insertion Tubes should always
20. SBB STar Array Electrode Insertion Tube 6ea SCC SCC STar Array Electrode Insertion Tube Stylet 2ea SDD SDD STar Array Insertion Tube Extractor SEE Array Electrode pin positions in slots BACK SEE KK Array Lead Insertion Tube e JOP SA ere weg LL Array Lead Insertion Tube Stylet ein hm SB MM Array microelectrode Medtronic FC2001 E Jr u FHC 22675L Z View e 3eaSC _ ME Drive shown with STar Frame Adapter SAA for Leksell Stereotactic System S SBB SCC Drive at Zero Drive at Target d Ue d Woch J Om m E SE E i E15 all E45 1 83 mm 20 9 O 2 25 5 25 CO Ess gt gt 1 60 1 83 mm J l au G Zi E 5 8 KC r 80 55 mm gt a e I CY re aa of ai el Aa ol ai 0 60 0 90mm S STar Frame Adapter e for Leksell N mo Stereotactic System e with Lower Arm Bushing ee SEN R I u Contact 188 5 mm Im 28mm rn 10mm an a 28 mm Drive at Zero 30 mm i Target Target Drive at Target O L011 1007 pg 19 amp 20 Rev D1 February 2012 Single Electrode Insertion Tube Set Procedure Position the Insertion Tube WARNING The Insertion Tube will enter the brain at this stage WARNING Never move the Insertion Tube in the brain without a Stylet or electrode inside WARNING When there is an Insertion Tube in the brain every effort should be made to minimize lateral forces to the microTargeting
21. STar Drive System as it can translate into significant lateral movements of the tube in the brain 1 Adjust the Drive to zero use the Remote Control if a motor is attached otherwise turn the knob Directions for Use of the STar Drive M E and Manual version are similar Illustrations herein show the WE version with accessories Manual Drive users should disregard the sleeved Motor shown in pictures and any instructions labeled with W 2 Insert the Insertion Tube and Stylet in the desired track 2a The Insertion Tube and Stylet are inserted LO11 1007 Rev D1 February 2012 21 Position the Microelectrode 5 Insert the Electrode Carrier making sure 3 Remove the Stylet the holes align with the bushing holes a 6 Secure the Electrode Carrier 4 Insert the Spacer Tube 7 Retract the microelectrode 15mm 4a The Insertion Tube and Spacer Tube are inserted 22 microTargeting STar Drive System Directions for Use Establish Electrical Connections and Begin Microelectrode Recording WARNING Improper cable connections may cause erroneous results including unintended stimulation through metal contacts in the brain 8 Insert the microelectrode in the Carrier and the Spacer Tube until the micro electrode stop comes flush to the Carrier 10 Establish electrical connections and advance the Drive Use the Remote Control if a Motor is attached otherwise turn the
22. Single Electrode frame configuration STar Array Electrode frame configuration Ordering information ee Ordering information Ordering information Cat Non Distance to FHC Medtronic 70 AC 01 C1010 Non Sterile STar Single Electrode Carriers includes 2ea Y Sterile Set Target mm 66 IT 01P Sterile Single Electrode Insertion Tubes includes AA BB CC pk 5 40 mm above target 66 IT 01 40mm 66 IT 01 Non Sterile Single Electrode Insertion Tube Set includes AA 66 IT 09 30mm BB CC DD Standard tube ends at 40 mm above target 66 IT 13 25mm See table with additional lengths 66 IT 05 20mm 6
23. Stop micro Targeting STar Drive M E BB CC I AA GG 10 98 gt ul ui D0 JE x Alignment 1 60 1 83mm e Adapter 0 55 mm a Multilumen 0 S Adapter Nexframe DR 4 Stereotactic 7 H o System 0 58 1 5 mm Cs Ser E A E 3 E g o D gt g amp 8 r o Ner 8 er S G S O Dp T I Q Q 2 3 Ss a a G i Skull surface to Target Probe Tip to 7 i eg 70 mm microelectrode tip Tip of Probe E z Distance To Advance Spe STar Drive to Target fom eg 15 mm Target I e 50 microTargeting STar Drive M E System Directions for Use STar Array Electrode Nexframe configuration
24. ay Nexframe Electrode Insertion Tube SCC STar Array Nexframe Electrode Insertion Tube Stylet SDD STar Array Insertion Tube Extractor Lead Desi Sto H SEE Array Nexframe Electrode pin positions in slots H H KK Array Nexframe STar Drive Lead Insertion Tube GAA LL Array Nexframe STar Drive Lead Insertion Tube Stylet MM Array Nexframe STar Drive microelectrode SBB SCC micro Targeting miL STar Drive M E I 7 7 Aint EH E5 10 1 83 mm 5 15 E 20 OK 2 E E30 Alignment IS SE Adapter D CZ SZ 3 Multilumen S D Adapter Nexframe 2 YOO gt Stereotactic Hl u Ierd System L Or an Jol 9 8 puni 1 uU I LIT 0 60 0 90 mm IN f 1 60 1 83 mm TOOT 90 55 mm x E d A 7 d S E E E d gt ay Q x 8 x Leni er gt E We g 5 2 3 s 5 EI E g Q Skull surface to Target l e Probe Tip to 5070 mm microelectrode tip Tip of Probe Distance To Advance to gel i STar Drive to Target 15 mm We gr eg 15 mm Target I Target O K I 1011 1007 Rev D1 February 2012 51 BrainLAB Micromar Adapter BrainLAB AG Ammerthalstrasse 8 85551 Heimstetten Germany 297 9mm 193 9 mm microTargeting STar Drive System Directions for Use 52 Warranty and Service CAUTION Unauthorized field repairs may affect calibration and function Units requiring repair should be returned to FHC or an authorized representative for service All FHC pro
25. ctrode 15mm 7 Remove the Stylet s 9 Insert the microelectrode s 10 Push the microelectrode s down 30 micro Targeting STar Drive System Directions for Use ES Establish Electrical Connections and Begin Microelectrode Recording WARNING Improper cable connec tions may cause erroneous results including unintended stimulation through metal contacts in the brain 10a The top view of a five microelectrode setup 11 Establish electrical connections and advance the Drive Use the remote control if a motor is attached otherwise turn the knob 10b Five microelectrodes are extended 12 Begin recording 13 Confirm the anatomical areas LO11 1007 Rev D1 February 2012 31 D Removing Electrodes 14 Remove electrical connections 15 Retract all microelectrodes and remove the microelectrode of the selected track 32 16 Loosen the screw of the carrier holding the Insertion Tube of the selected track me II 17 Remove the Insertion Tube of the selected track by inserting the tube extractor with slight force into the Insertion Tube and pulling upwards micro Targeting STar Drive System Directions for Use Begin the 40cm Lead Implant 18 Repeat step 17 to remove the insertion guide tube of the selected track 19 Remove all remaining microelectrodes 20 Insert the lead Insertion Tube and Stylet 21
26. de Distance is shown in microns or millimeters depending on the operator s prefer ence The arrow symbol in front of the position number indicates direction of travel or will point to the position readout at rest WARNING In the event of any Drive Acces sory failure erratic function or motor stall remove it and proceed using the microTar geting STar Drive M E manually WARNING During the procedure periodi cally compare the physical scale depth read ing with Controller reading to ensure proper operation If the two scales differ by more than 25 microns discontinue use of the Display Unit and proceed manually WARNING The microTargeting Controller has been factory set to enforce a software drive limit of 50mm which corresponds with the maximum travel of the microTargeting STar Drive M E This limit may be changed through the serial interface of the micro Targeting Controller However setting the limit beyond 50mm could result in drive travel beyond the range of the Drive 19 16 Motor Encoder Accessories Controller Display Module continued Remote Control Calibration If needed With the Motor Assembly and Remote Control connected and the power on press on the Retract to Zero button on the Remote Control for at least 5 seconds to enter the calibration menu The display will show REMOTE CALIBRATION ADVANCE Turn the knob in the fully clockwise position then while holdin
27. ducts are unconditionally guaranteed against defects in workmanship for one year from date of shipment as long as they have been exposed to normal and proper use Should service or repair be required please contact our 24 hour Technical Service for return authorization and shipping instructions or visit www fh co com FHC_Service htm Please include a note indicating The model number serial number and purchase date of the instrument The name of the Purchaser The name and contact information of a person to contact if questions arise The symptoms indicating that repair is necessary oR WN Disposal at End of Product Life Cycle Astatement that the instrument is being shipped free of any biological contamination Equipment may be returned to FHC In Bowdoin Maine USA freight pre paid for proper disposal recycling FHC FHC Inc FHC Europe w i 1201 Main Street EU REP TERMOBIT PROD srl Bowdoin ME 04287 129 Barbu Vacarescu Str Sector 2 CE Fax 1 207 666 8292 Bucharest 020272 0413 Wwww fh co com Romania 24 hour technical service EI 1 800 326 2905 US amp Can 1 207 666 8190 Innovation through collaboration FHC Latin America Carrera 43 A 1sur 31 Ed BBVA oficina 401 Medellin Colombia
28. e the indent is aligned with the locking thumb screw and the slot is aligned with the opening of the drive positioning platform 3 Secure the Carrier by tightening the thumbscrew 28 microTargeting STar Drive System Directions for Use WARNING The Insertion Tube will enter the brain at this stage WARNING Never move the Insertion Tube in the brain without a Stylet or electrode inside 4 Insert the STar Array insertion guide tube s Ensure it is fully seated in its recess 5 Insert the STar Array Insertion Tube s The top of the collar should come flush with the top surface of the STar Array Locking Carrier Note For multiple tubes repeat steps 4 and 5 As many as 5 microelectrodes may be used for simultaneous recording L011 1007 Rev D1 February 2012 5a The guide tube s Insertion Tube s and Stylet s are inserted 6 Secure the Insertion Tubes s by tightening the screw s of the carrier Use the hexwrench or the wire tool provided for hard to reach screws as shown above WARNING When there is an Inser tion Tube in the brain every effort should be made to minimize lateral forces to the microTargeting STar Drive System as it can translate into significant lateral movements of the tube in the brain CAUTION Do not over tighten these screws as it may damage the Insertion Tubes 29 Position the microelectrode 15mm 8 Retract the microele
29. g STar Drive System Directions for Use 25 Hold the lead with smooth tip rubber coated tweezers or use the lead locking device 26 Remove the Drive System several methods may be used If the lower guide is used it may be necessary to remove it from the Drive prior to removing the Drive System Proceed to Page 38 for instruc tions on dismantling equipment after use LO11 1007 Rev D1 February 2012 28 Array Electrode Insertion Tube Set Procedure WARNING In the Array Electrode Insertion Tube Procedure the Drive System is designed to be used with the STar Array Insertion Tube Set refer to chart on page 20 If you are using other tubes you need to purchase a Lower Guide for the Drive See page 19 and refer to the Lower Guide Directions for Use a 1 Advance the Drive to the initial start position use the Remote Control if a Motor is attached otherwise turn the knob Directions for Use of the STar Drive M E and Manual version are similar Illustrations herein show the WE version with accessories Manual drive users should disregard the sleeved Motor shown in pictures and any instructions labeled with W Position the Insertion Tube 2 Make sure the screws of the array carrier are partially manually tightened such that they only have to be turned a small fraction 45 to 90 of a turn to secure the tubes in place Insert the STar Array Locking Carrier making sur
30. g the knob in the full clockwise position press and release the retract to zero button The display will show RETRACT Turn the knob all the way counterclockwise and hold it while pressing the Retract to Zero button This calibration procedure may need to be repeated several times Check again for correct function and if any errors are noted the units should be returned to FHC for service micro Targeting Controller Stall Detection In the event of a stall make certain there is no physical obstruction A stall algorithm has been provided so that if a stall is detected during Drive movement the word STALL will appear on the display and the Drive will stop moving then the position number will be redisplayed but the Drive will not continue moving To restart turn the knob of the remote control The number displayed should be checked against the Drive s physical scale A small discrepancy of less than 25 microns is not a cause for concern Discrepancies of over 25 microns or frequent stall warnings indicate repair is necessary In order to complete the procedure disconnect accessories and proceed using the manual advancement knob FHC should be contacted for service or repair Mounting the Drive on the Stereotactic System Mount the assembled system onto the stereotactic system and secure it as shown on pages 39 52 Make sure the securing screws are tight to prevent movement or rotation Confirm t
31. hat the Drive mounts securely on the frame mount WARNING Always confirm the tightness of thumbknobs especially those holding the frame adapter before beginning the procedure The stereotactic adapter must be securely held in the frame mount so that the STar Drive System cannot move or rotate WARNING The Motor Encoder should be attached to the Drive before it is mounted on the stereotactic system to avoid exposing the assembly mounting pins to the patient sterile field microTargeting STar Drive System Directions for Use Preparing the 40cm Lead for Implant A Measuring Fixture B Depth Stop Adapter 1 8mm Note Preparation should be done C Lead Holder in a sterile area Lead not shown 3 Place the Depth Stop Adapter 1 8mm loosely on the lead 1 Attach the Lead Holder to the Measuring Fixture 4 Insert the lead and Depth Stop Adapter 1 8mm into the Lead Holder Wr ro 2 Secure the Lead Holder to the Measuring Fixture 5 Secure the Depth Stop Adapter 1 8mm LO11 1007 Rev D1 February 2012 17 Preparing the Lead for Implant continued 6 Position the lead contact area atthe end of the Measuring Fixture 9 Remove the Lead Holder and lead with preattached Depth Stop Adapter 1 8mm from the Measuring Fixture 7 Tighten the lead WARNING Do not over tighten this screw as it may damage the lead 10 Remove the Depth Stop Ada
32. he Motor and the Drive CAUTION Pre use check should include retracting or advancing the Drive Motor using the handheld remote Confirm that the knob can be turned to its clockwise advance and counterclockwise retract limits and when released returns to the center position No movement of the Drive should occur when the remote control knob is in the center rest ing position If there are any abnormalities perform the calibration procedure See page 16 1011 1007 Rev D1 February 2012 3 If a Motor is used set the Drive to zero by using the remote control If an Encoder is used turn the advancement knob to zero Press the zero button labeled 9 front panel on the Module to set the LED display to 00000um WARNING Always confirm that the microTar geting STar Drive WE is set at 0mm when zeroing the microTargeting Controller As a safety feature the Display Unit cannot be re zeroed without powering off the Module Not doing so will cause the Drive limit to be incorrect and also will cause the Controller Display to be out of sync with the drive posi tion as read on the drive scale CAUTION Do not zero the Display Unit until prompted Failure to do so will result in dis play errors When the Drive is advanced the position report on the LED will be updated and will show either the real distance traveled from the zero position or the distance from the target location depending on the distance mo
33. ic system WARNING Do not use Insertion Tubes and microelectrodes other than those which have been specifically designed for use with Nexframe STar Drive LO11 1007 Rev D1 February 2012 49 STar Single Electrode Nexframe configuration 66 AC AR Ordering information FHC Vedtronic 66 AC AR Non Sterile Array Carrier and Clamp Includes DD EE FF 70 IT 3007 C9003 Sterile Single Insertion Tube Set pk 5 Includes AA BB CC 5700R Sterile Nexframe STar Drive mT Electrode pk 5 5705L ir Sterile Nexframe STar Drive DZAP Leadpoint mT Electrode pk 5 Sterile Nexframe STar Drive DZAP mT Electrode pk 5 AA Insertion Tube EE BB Stylet W VIEW CC Spacer Tube for Nexframe microelectrodes DD Array Electrode Carrier 66 AC EC S EE Shielded Array Clamp 66 AC SC FF FF Non shielded Array Clamp 66 AC NC GG Sterile Nexframe STar Drive mT Electrode HH Single Electrode pin position in slot _ Lead Depth
34. in slots Au KK Array Platform Lead Insertion Tube l LL Array Platform Lead Insertion Tube Stylet MM Array Platform microelectrode 44970R Be WE Drive shown with 120 mm model Platform es CC Drive at Zero Drive at Target M th a 7 g DD bugs 2109 7 uliuli uliu 7 O A Sec l 15 1 83 mm gt u 30 F 1 60 1 83 mm N f A A J F 2 ZA D ve al l fol oh YOT alt Tol Lob EN Gei H STD 0 60 0 90 mm y E i i E lt f d Macro Contact d E 1mm x 26 mm Q 10mm mS I Er E e U 8 27 mm 124 mm a Drive at Zero i 30 mm Target A Target A Drive at Target N 1011 1007 Rev D1 February 2012 45 46 Radionics Offsetting Adapter Radionics Inc 22 Terry Ave Burlington MA 01803 USA WARNING Separate collet and adapter prior to cleaning and sterilization CAUTION Due to sharp edges and pinch points handle collet and adapter carefully micro Targeting STar Drive System Directions for Use SEN EEE LA 292 5 mm 47 1011 1007 Rev D1 February 2012 Leksell Offsetting Adapter Elekta AB Birger Jarlsgatan 53 Box 7593 SE 103 93 Stockholm Sweden micro Targeting STar Drive System Directions for Use 48 Nexframe Adaptation ATTENTION See Nexframe System manual WARNING Nexframe STar Drive Insertion Tubes and microelectrodes should not be used with any other drive or stereotact
35. knob 9 Secure the microelectrode in the Carrier push the microelectrode down 7 F J F 11 Begin recording CAUTION Do not over tighten this screw as it may damage the microelectrode 12 Confirm the anatomical areas 1011 1007 Rev D1 February 2012 23 Removing Electrodes 13 Remove electrical connections and 15 Remove the Spacer Tube loosen the Carrier Locking Screw 16 Additional tracks are available and 14 Remove the microelectrode and the require the Insertion Tube to be Carrier removed and steps 1 15 repeated 24 microTargeting STar Drive System Directions for Use Begin the 40cm Lead Implant 17 Attach the Lead Holder to the Drive positioning platform 18 Insert the preset lead into the tube and secure the Depth Stop Adapter 1 8mm in the Lead Holder LO11 1007 Rev D1 February 2012 19 The lead is inserted into the tube 20 Confirm the lead location Use the Remote Control if a Motor is used otherwise turn the knob WARNING Observe the exposed segment of the lead while advancing the Drive and ensure it advances into the Insertion Tube without binding or bending 25 Remove the Drive and Insertion Tube 23 Remove the Stylet from the lead 21 Raise the Insertion Tube 24 Loosen the Depth Stop Adapter 1 8mm screw 22 Hold the lead with smooth tip rubber coated tweezers next to the skull 26 microTargetin
36. ll 36 micro Targeting STar Drive System Directions for Use 36 Remove the Drive System several methods may be used 1011 1007 Rev D1 February 2012 31 38 Dismantling Equipment After Use A If a STar Drive M E is used with the Motor or Encoder Accessory remove it from the drive and unplug it and the Remote Control from the Controller Disconnect the Power Supply from the Controller and the Line Cord from the power receptacle Discard the sterile drape In the event these accessory components become soiled they should be wiped clean with an Isopropyl Alcohol dampened cloth then dried Do not immerse Accessories in fluids or allow excessive moisture to remain Set aside the micro Targeting STar Drive the Carrier and the Stereotactic Frame Adapter in the Sterilization tray including the verification probe and spare parts for disassembly and cleaning page 5 7 This equipment should be stored where it s available for the next procedure micro Targeting STar Drive System Directions for Use Frame Adapters Radionics CRW Adapter Radionics Inc 22 Terry Ave Burlington MA 01803 USA WARNING Separate collet and adapter prior to cleaning and sterilization CAUTION Due to sharp edges and pinch points handle collet and adapter carefully ef A i al Be Du fen a ay Ps gt a ae ef ony pr a F Pr d Fi 2 r Fu d d v i eil Gi d ef L wi i ei ef wi a j ef e ae
37. ng the Draped Assembly 1 Remove the protection cover of the Drive 4 When the pins are felt to engage gently push the Assembly all the way down to the top cover of the Drive Make sure no folds of the sterile drape are caught between surfaces 2 Pick up the assembly and insert the two long alignment pins slightly into the holes in the top WARNING Always confirm the Encoder cover There is no incorrect way to align the pins or Motor Assembly seats squarely on the Do not force the assembly any further at this time Drive A misalignment may result in a stall See page 16 CAUTION Never turn the manual advance 3 Push down lightly on the Assembly while turning ment knob on the microTargeting STar he Drive advancement knob slowly Drive M E while a motor is engaged This Since the center drive plate of the Encoder can damage both the motor and the Drive Assembly if used turns so easily it may be necessary to pull it away from the turning plate in the Drive slightly and push down lightly several times before alignment occurs Do not attempt to force engagement as damage to the mechanism can occur LO11 1007 Rev D1 February 2012 13 Motor Encoder Accessories Mounting the Draped Assembly continued Motor Encoder Accessories Controller Display Module WARNING Position connecting cables and leads where they will not be inadvertently pulled or tangled Lg WARNING Do not operate the contr
38. oller unit in the presence of flammable anesthetics Lg WARNING Do not connect simultaneously an Encoder Assembly and a Remote Control into the microTargeting Controller or this will result in display errors 5 Tighten the Assembly locking knobs securely Warning Motor Arape sieeve SIENU IE and test the Assembly for secure attachment compromised at any time during the proce 14 dure it must be replaced and the process begun again as described on Page 11 CAUTION The accessory components should be inspected visually prior to each use for physical damage frayed or kinked cables or damaged connectors 1 It is assumed at this point that either the Encoder or Motor Assembly is draped and attached to the Drive e Ensure the power supply s line cord is plugged into a power outlet e Connect the Assembly to the Module by inserting its connector into the corresponding socket on the front panel labeled with the following symbol e f using the Motor Assembly connect the Remote Control to the Module front panel mating connector labeled with the following symbol AO e Connect the power supply to the Module back panel CAUTION Alternative power supplies and sources are not authorized for use with this equipment and may cause malfunction or injury microTargeting STar Drive System Directions for Use 2 Activate the ON OFF switch in the back panel of the Module CAUTION If the Retract
39. omponents as shown below Tray with correct positioning of all sterilizable components micro Targeting STar Drive System components Drive carrier and frame adapter that require sterilization Shown with A STar Array locking carrier and B STar Frame Adapter for Radionics CRW LO11 1007 Rev D1 February 2012 5 Cleaning of Sterilizable Components Fl CAUTION The cover is provided to protect the opening of the STar Drive M E when an accessory is not attached Failure to use the cover could allow debris to enter the drive mechanism The cover should be removed during cleaning and sterilization to allow proper drainage from this mechanism The cover should be kept in the sterilization tray basket so that it is available in case the drive is to be transported or stored in the tray without the sterile wrap ES WARNING None of the Drive Electronic Accessories should be cleaned or sterilized using the methods described on pages 6 7 use the sterile draping system as described on pages 11 12 to assure they do not contaminate the sterile field and the procedure on page 38 to remove any soiled materials Refer to system diagram on pages 19 20 for the components identified with letters listed below Manual Cleaning re BE STar SteriSuite case needed L Drive and its Components STar Drive WE with cover removed J STar Drive Lead Holder M Electrode Depth Sto
40. play Module Mounting the Drive on the Stereotactic System Preparing the 40cm Lead for Implant STar Drive System Components Single Array and Lead Components Single Electrode Insertion Tube Set Procedure Array Electrode Insertion Tube Set Procedure Dismantling Equipment After Use Frame Adapters Radionics CRW Adapter Leksell Stereotactic System Adapter Leibinger RM Adapter Leibinger ZD Adapter micro Targeting Platform Adapter Radionics Offsetting Adapter Leksell Offsetting Adapter Nexframe Adaptation BrainLAB Micromar Adapter Warranty and Service Disposal at End of Product Life Cycle instructions labeled with J LO11 1007 Rev D1 February 2012 micro Targeting STar Drive System Accessories and Stereotactic Adapters Indications for use The microTargeting STar Drive System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes stimulating electrodes or other instruments in the brain or nervous system Contraindications Follow the general guidelines concerning the suitability of neurosurgery involving the insertion of electrodes instruments or devices Warnings f WARNING If any error or erratic function is observed discontinue use of the Drive System immediately and evaluate the potential impact to patient safety before continuing its unmitigated use Lg WARNING Prior
41. ps O Y X SA SB Measuring Fixture N Frame Adapter S T U V YY ZZ Verification Probe A Insertion Tubes and Spacer Tubes AA BB CC KK LL SAA SBB SCC SDD Prepare the detergent according to manufacturer s recommendations Asepti Wash Plus liquid 2 5 ml per liter or 1 4 oz per gal using warm tap water Separate the Drive stereotactic adapter and Lead Holder and immerse them in the wash solution for a minimum of 5 minutes Actuate the devices during the soak Using a clean soft cloth that has been soaked in the detergent wipe the tray and its insert to remove any visible soil Use a soft bristle brush and syringe to reach hard to clean areas Place the Drive and its components back in the tray Prepare the detergent in a sonication unit according to manufacturer s recommendations Asepti Wash Plus liquid 2 5 ml per liter or 1 4 oz per gal Immerse the tray in the sonication unit and sonicate for a minimum of 10 minutes Rinse all components with running reverse osmosis de ionized water to remove any residual detergent Dry components using a clean soft cloth Visually inspect to ensure all visible soil is removed Immediately following use thoroughly rinse each tube and other components separately under tap water Repeatedly insert the Stylet or Spacer Tube cleaning tool in and out of the tube under running tap water to dislodge any debris or coagulated fluid
42. pter 1 8mm from the Lead Holder and set aside ina sterile area for later use 8 Loosen the Lead Holder 18 microTargeting STar Drive System Directions for Use micro Targeting M STar Drive System Stereotactic frame configuration Ordering information FHC Medtronic J STar Drive Motor Encoder DI Drive Motor and Encoder Accessories 70 ZD ME A Verification Probe 66 IT VP B Positioning platform C Electrode carrier locking screw STar Drive Manual 70 ZD MA
43. stem and its associated insertion tubes are not MRI compatible CAUTION When tightening the STar Array Locking Carrier screws that are difficult to reach by hand use only the tool provided When tightening all other screws and thumbknobs hand tighten only Overtightening can cause damage to the Drive System and adversely affect targeting Symbol Key Warnings should be read carefully because if they are not heeded they could lead to situations which may result in serious injury or death Rx Only Zero AO Remote Control E Hand Tighten Securely Retract O Off On Power Assist or Display Assembly Advance 2 Type BF Equipment electrically isolated from patient Retract to Zero Sterile STERLE Non sterile O oO CH Serial Communications Port micro Targeting STar Drive System Directions for Use Disassembly for Cleaning and Storage or Sterilization Store the microTargeting STar Drive System and Using a clean soft cloth that has been soaked in the detergent when applicable the Motor Encoder Accessories at solution page 6 Wipe the tray and its insert to remove any temperatures between 34 C 29 F and 57 C 135 visible soil Use the soft bristle brushes to reach hard to clean Do not exceed 135 F for long term storage areas especially the lumen of the Frame Adapter Guide Tube Remove and put the small extra parts in the basket then Ste ri iza D e com po ne nts position the other c
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